Manual suction curettage instruments

ABSTRACT

A disposable aspiration system for the manual performance of abortion during early uterine gestations includes a scoop-like curette tube adapted to be inserted in the vaginal uterine tract and an aspirator connected to the curette tube. In one form of the invention, a stopcock assembly is included between tube and aspirator to permit discharge of the aspirator during intermediate steps of the tissue removal process.

United States Patent Elmaleh 1March 20, 1973 1 MANUAL SUCTION CURETTAGE2,715,899 8/1955 MacLean ..l28/304 x INSTRUMENTS 3,506,010 4/1970 Murr..128/276 [75] Inventor: Leonard R. Elmaleh, New York, FOREIGN PATENTSOR APPLICATIONS 226,791 9/1968 U.S.S.R ..128/278 [73] Assignee: SollyScheiner, Great Neck, N.Y. [22] Filed; Jam 28 1971 PrimaryExaminer-Lucie H. Laudenslager Attorney-Stanley J. Silverberg [21]App1.No.: 110,407

[57] ABSTRACT [52] US. Cl. ..128/304, 128/278, 128/302 A disposableaspiration System for the manual Pen [51] Int. Cl. ..A61b 17/42 formanceof abortion during early uterine gestations [58] held of Search"128/273, 1 includes a scoop-like curette tube adapted to be in- 128/30427/2411 24A serted in the vaginal uterine tract and an aspirator 56connected to the curette tube. In one form of the in- 1 References andvention, a stopcock assembly is included between tube UNITED STATESPATENTS and aspirator to permit discharge of the aspirator duringintermediate steps of the tissue removal process. 1,215,512 2/1917Fetzer .Q ..l28/278 X 2,421,959 6/1947 Norris 128/278 5 Claims, 3Drawing Figures MANUAL SUCTION CURETTAGE INSTRUMENTS BACKGROUND OF THEINVENTION This invention relates to manually operated suction curettageinstruments for performing abortions during an early stage of pregnancy.

The substantial increase in the number of abortions of pregnanciescurrently being demanded and performed as a result of the recentrelaxation of abortion laws in a number of states has created severaldistinct problems relative thereto. First, the mere increase in thenumber of applicants has frequently resulted in a substantial waitingperiod in order for the patient to enter a hospital. This can, initself, result in difficulty since the longer an abortion is delayed,the greater is the risk of complication.

Second, the instruments used in hospitals are relatively expensive, andnon-portable, such as a Berk vacuum machine using a Vacurette aspiratingtube which may cost up to $1,000 and which has substantially more vacuumpressure than necessary for use in abortions of early stage uterinegestations. The maximum aspiration pressure of such machines istypically 100 mm of Hg. and the complete pressure range can be traversedquite rapidly. On occasion, since satisfactory aspiration pressure isdependent upon the physical characteristics of the individual person,the use of a machine with such pressure capability may prove unsafe.

There is, therefore, a real need for an inexpensive, simple, safe, andportable system which may be readily used in the offices of a qualifiedphysician. Such a system would enable the cost attendant with abortionsto drop substantially and be within the economic reach of many personscurrently unable to afford an abortion. Such a system would also enableabortions to be performed at their earliest possible stage without thesignificant delay encountered with hospital abortions. Finally, it wouldenable the abortion to be performed by a system designed for theearliest stages of pregnancy where a lower aspiration pressure may beincorporated, thus, avoiding any dangers in the use of excessive,unnecessary pressure; such lowered pressure also improving thesensitivity with which the instrument may be used.

SUMMARY OF THE INVENTION It is, therefore, an object of the presentinvention to provide manually operated apparatus for the performance ofabortions during an early stage of uterine pregnancies.

It is also an object of the present invention to provide manuallyoperated aspirating apparatus for the performance of abortions during anearly stage of uterine pregnancy which uses a lower maximum aspiratingpressure than prior such apparatus.

It is another object of the present invention to provide manuallyoperated aspirating apparatus for the performance of abortions during anearly stage of uterine pregnancy which is relatively inexpensive tomanufacture, is simple to operate, and is safe to use.

It is still another object of the present invention to provide manuallyoperated apparatus for the performance of abortions during an earlystage of uterine pregnancy which is portable and also completelydisposable after use.

It is still a further object of the present invention to providemanually operated apparatus for the performance of abortions during anearly stage of uterine pregnancy which has greater sensitivity andcontrol than prior such apparatus.

In accordance with the present invention, apparatus for the manualremoval of fetal tissue during early uterine gestations includesanelongated curette tube having distal portion and a proximate portion.The tube has a distal opening at the end of the distal portion and aproximate opening at the end of the proximate portion. The proximate endand distal end form an angle slightly less than which substantiallycorresponds to the angle of vaginal-uterine tract of a human female. Thecurette tube distal portion is adapted to be inserted in the vaginaluterine tract of pregnant female. Also included is a manually operatedaspirator having a cylindrical portion and a plunger portion. Theaspirator has an opening at one end communicating with the proximateopening of the curette tube. The plunger portion is disposed within thecylindrical portion and forms a hermetic seal therewith. The plungerportion is adapted for linear movement within the cylindrical portionand is capable of creating a suction at the distal opening of thecurette tube in response to the linear movement of the plunger wherebymaterial may be drawn through the distal opening into the cylindricalportion of the aspirator.

In one form of the invention, a manually operated stopcock, capable ofbeing used in one of two operable positions is disposed between thecurette tube and aspirator. The stopcock has an inlet portion, an outletportion, and a discharge portion, the inlet portion being coupled to theproximate opening, the outlet portion coupled to the aspirator openingand the discharge portion adapted to being coupled to a collectingelement. The stopcock is used for directing the flow of material fromcurette tube to aspirator in a first and normal position, the dischargeportion being blocked in this position, and for directing the flow ofremoved material between aspirator and discharge portion in a second anddischarge position.

For a better understanding of the present invention, together with otherand future objects thereof, reference is made to the followingdescription, the scope of the invention being set forth in the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings:

FIG. 1 illustrates a partially sectioned elevation view of the presentinvention.

FIG. 2 illustrates a cross sectional view of a two-way stopcock of thepresent invention in one position of its use.

FIG. 3 illustrates a cross sectional view of the twostopcock of thepresent invention in another position of its use.

DESCRIPTION AND OPERATION OF THE APPARATUS Referring first to FIG. 1,shown there is the over-all hand operated suction curettage instrumentof the present invention. The instrument comprises in its basic form,two parts, the curette tube 10 and the handoperated suction device oraspirator 20.

The curette tube 10 is a hollow, scoop-like tube substantiallycylindrical in shape having a distal opening 1 l at one end and adaptedto be connected to the aspirator 20 at the opposite end. The distalopening 11 is angular and of relatively substantial size. Morespecifically, opening 1 1 essentially represents the intersection of animaginary plane at a steep angle with the cylindrical tube. The end ofthe distal portion 12 of the tube 10 is intended to be inserted into theuterus of the patient with opening 1 1 juxtaposed to the fetus. The endof the distal portion 12 forms a slight angle elbow 13 with the end of aproximate portion 14, thereby more or less following the shape of thevaginal and uterine portions of the female body. Proximate portion 14also has a proximate opening 14a at the end thereof remote from thedistal portion 12.

Along the straight part of the proximate portion 14 of the tube 10 butclose to the elbow 13 may be inscribed a series of calibration marks 15.As shown in FIG. 1, these calibration marks are indicated as 7 cm-l cmwhich represents the measured length of the tube 10.

In a simplified form of the present invention, the curette tube may bedirectly connected to the aspirator without the use of a stopcockarrangement, which will be described in greater detail below. In thisform, the proximate end of the tube 10 is coupled to the aspirator 20 bya hermetically sealed connector 18, such as a connector knowncommercially as a Luer-Lock. Such connection may be a threaded one,wherein the tube is screwed together with the aspirator at connection18.

The aspirator 20 is a typical piston-type syringe having a plunger orpiston portion 21 and a cylinder portion 22. At the head 23 of theplunger portion 21 is fastened a narrow cylindrical elastic element 23typically made of rubber. Head 23 must intimately contact the internalwalls of cylinder 22 to form a hermetical seal regardless of theposition of the plunger portion 21. The cylinder portion 22 may includeflanges 24 at the end of cylinder 22 to improve its ability to be heldduring use.

The aspirator 20 and curette tube 10 may be constructed of a disposableplastic, such as polyethylene or polypropylene.

In this form of the invention, the tube 10 may be also made integralwith the aspirator 20 in a one-piece arrangement. This would represent amost economical and easily disposable form of the invention.

In the case of this form of the invention, the plunger 21 is firstpushed forward and the distal end of the curette tube 10 is insertedinto the uterus after anesthetizing the patient with other general orlocal anesthesia and the cervical opening is dilated. In the very earlystages of pregnancy, a local anesthetic will likely suffice.

The aspiration system is used by first pushing the plunger 21 forwardand inserting the curette tube 10 in the vaginal uterine tract.

The opening 11 of the tube 10 is juxtaposed to the fetal tissue to beremoved. The plunger or piston 21 of the aspirator is then pulled back(no further than the cylinder end), creating a sufficient partial vacuumto fill up the cylinder 22 by suction. A 35cc or 50cc aspirator capacitywill be sufficient in most cases. In the stages of pregnancy up to 9weeks, there will generally be, at most, two such tissue withdrawalsrequired. In the very early weeks of pregnancy or if a larger (50cc)capacity aspirator is used,.one fill up will remove all fetal tissue.After each fill up of the cylinder, the entire unit must be withdrawnfrom the patient and emptied.

Since a preferred technique is to leave the instrument in place, ratherthan remove it, to empty its contents, the second form of the inventionhas been devised. In this arrangement, a two-way stopcock 16 is insertedbetween the proximate end 14 of the curette tube 10 and the sealedconnector 18. Stopcock 16 may be a separate device which may beincorporated between tube 10 and aspirator 20 by another sealedconnector 26 and connector 18. Alternatively, the stopcock 16 may beconstructed integral with the curette tube 10, thus forming a unitaryelement.

In either case, the stopcock 16 is incorporated between the curette tube10 and aspirator 20 and includes a rotatable protusion 17 for moving thestop-. cock between positions. The stopcock 16 also includes an exittube 30 that is coupled to collecting tube 19 by a hermetically sealedconnector 27 for discharging the removed tissue into collecting bottle34.

In FIGS. 2 and 3, the two positions of the stopcock are shown in crosssection. Referring to FIG. 2, the stopcock includes a fixed collar 25which retains and supports the movable central portion 31. Centralportion 31 includes a through duct 28 which passes diametrically throughthe central portion 31. At right angles to the through duct 28, withinthe central portion 31 and communicating with duct 28, is a duct 29 ofradial length. Collar 25 has openings 35, 36, 37 in line with the tubeportions 32 and 33 and exit tube 30. In the normal connection of thestopcock 16 shown in FIG. 2, the removed tissue enters tube portion 32,passes through collar opening 35, through duct 28, out of collar opening36, and into tube exit portion 33. Tube portion 33 leads to theaspirator 20. In this position, duct 29 leads to a blind exit and theopening 37 is blocked by the central portion 31 to prevent any materialfrom entering there.

It is preferred that the stopcock ducts 28 and 29 be of similar diameterto that of the curette tube 10 in order that the capacity of the systembe unimpaired and to prevent clogging of the stopcock 16.

On the discharge position shown in FIG. 3, the movable central portion31 is rotated counterclockwise degrees from the normal position. Collaropening 35 is now blocked and duct 28 faces collar opening 37 whichfeeds exit tube 30. Duct 29 faces collar opening 36 which feeds tubeportion 33. In this position, the fluid which had been extracted andtemporarily stored in the aspirator, is emptied so that the fluid enterstube portion 33, flows through duct 29 and through a portion of duct 28into exit tube 30 and connection 19 to the collecting bottle. Thisdirection of fluid is indicated by an arrow in FIG. 3.

The aspiration system, which includes the stopcock 16 is better adaptedfor later stage pregnancies (but generally less than 9 weeks), since theamount of material to be removed is greater. The use of the stopcock 16obviates any need to remove the curette tube 10 once it has beeninserted until all the fetal matter has been withdrawn. Thissignificantly simplifies the operation.

In use, the plunger 21 is pushed forward and the curette tube isinserted into the vaginal uterine tract, with the opening 11 juxtaposedto the fetus. The stop cock 16 would ordinarily be in the normalposition as in F IG. 2. As' before, the patient usually has been given ageneral or local anesthetic. After insertion and alignment of thecurette tube 10, the plunger 21 is pulled back and the tissue removed,so as to fill up the aspirator 20. In this form of the invention,adapted to later stage pregnancies, the 50cc aspirator capacity ispreferred. Once filled, the curette tube 10 is left in place, thestopcock 16 rotated to the discharge position (FIG. 3), and the plungerpressed downward. The collected material passes from the aspirator tothe collecting bottle. The stopcock 16 is then returned to the normalposition and the process repeated until all the fetal material isremoved.

The curette tube 10 is to be constructed of predetermined, outsidediameter which will vary depending on the stage of pregnancy. A range ofdiameters of 7 to 10mm will cover the range of pregnancies up to about 2V2 months. The following table indicates the suggested diameter tubeaccording to the stage of pregnancy.

Diameter Size Stage of Pregnancy 78mm 0-4 weeks 8-9mm 4-6 weeks 9-l0mm6-9 weeks on the amount of fetal material to be removed and the dilationrequired.

As the table indicates, the earlier the pregnancy, the smaller thedilation and the smaller the size of the curette tube generallynecessary to empty it.

As has been described above, the present invention provides a safe,portable and disposable apparatus for manually performing abortions ofearly uterine gestations. The apparatus and method is specificallyadapted for use in a doctors office as opposed to a hospital and,accordingly, offers a significant economy in such instruments andtherefore in the ultimate cost of early abortions. (The instrument may,of course, be used in a hospital if desired, since it also offersadditional advantages over presently available in-hospital systems interms of increased sensitivity, flexibility, and control.)

While there have been described what are believed to be the preferredembodiments of the present invention, many variations and modificationswill be obvious to those of ordinary skill in the art and it is intendedto cover all such changes and modifications as fall within the truespirit and scope of the present invention.

I claim:

1. Apparatus for the manual removal of fetal tissue tially correspondingto the angle of the vaginal uterine tract of a human female, saidcurette ube distal portion adapted to be inserted in the vaginal uterinetract of a pregnant female;

a manually operated aspirator having a cylindrical portion and a plungerportion, said aspirator having an opening at one end, said plungerportion disposed within said cylindrical portion and forming a hermeticseal therewith, said plunger adapted for linear movement within saidcylindrical portion;

and a manually operated stopcock capable of being used in one of twooperable positions, said stopcock disposed between said curette tube andsaid aspirator, said stopcock having an inlet portion, an outlet portionand a discharge portion, said inlet portion being coupled to saidproximate opening, said outlet portion coupled to said aspirator openingand said discharge portion adapted to being coupled to a collectingelement, said stopcock for directing the flow of material from curettetube to aspirator in a first and normal position, the discharge portionbeing blocked in this position, and for directing the flow of removedmaterial between aspirator and discharge portion in a second anddischarge position, whereby said apparatus is adapted to create asuction at said distal opening of said curette tube by linear movementof said plunger in one direction to draw material through said distalopening into said aspirator when said stopcock is in said normalposition and to discharge material collected in said aspirator by linearmovement of said plunger in an opposite direction when said stopcock isin said discharge position.

2. Apparatus as described in claim 1 wherein said curette tube,stopcock, and aspirator are constructed primarily of plastic and theentire apparatus is disposable after use.

3. Apparatus as described in claim 1 wherein said curette tube isdisconnectable from said stopcock and said stopcock is disconnectablefrom said aspirator.

4. Apparatus as described in claim 3, wherein said curette tube has apredetermined diameter size of 7 to 8 mm for pregnancies up to 4 weeksduration, of 8 to 9 mm for pregancies from 4 to 6 weeks duration, and 9to 10 mm for pregnancies from 6 to 12 weeks duration.

5. Apparatus as described in claim 4 wherein said distal opening issubstantially oval in shape.

1. Apparatus for the manual removal of fetal tissue during early uterinegestations comprising: an elongated curette tube having a distal portionand a proximate portion, said tube having a distal opening at the end ofsaid distal portion and a proximate opening at the end of said proximateportion, said proximate end and said distal end forming an angleslightly less than 180* substantially corresponding to the angle of thevaginal uterine tract of a human female, said curette tube distalportion adapted to be inserted in the vaginal uterine tract of apregnant female; a manually operated aspirator having a cylindricalportion and a plunger portion, said aspirator having an opening at oneend, said plunger portion disposed within said cylindrical portion andforming a hermetic seal therewith, said plunger adapted for linearmovement within said cylindrical portion; and a manually operatedstopcock capable of being used in one of two operable positions, saidstopcock disposed between said curette tube and said aspirator, saidstopcock having an inlet portion, an outlet portion and a dischargeportion, said inlet portion being coupled to said proximate opening,said outlet portion coupled to said aspirator opening and said dischargeportion adapted to being coupled to a collecting element, said stopcockfor directing the flow of material from curette tube to aspirator in afirst and normal position, the discharge portion being blocked in thisposition, and for directing the flow of removed material betweenaspirator and discharge portion in a second and discharge position,whereby said apparatus is adapted to create a suction at said distalopening of said curette tube by linear movement of said plunger in onedirection to draw material through said distal opening into saidaspirator when said stopcock is in said normal position and to dischargematerial collected in said aspirator by linear movement of said plungerin an opposite direction when said stopcock is in said dischargeposition.
 2. Apparatus as described in claim 1 wherein said curettetube, stopcock, and aspirator are constructed primarily of plastic andthe entire apparatus is disposable after use.
 3. Apparatus as describedin claim 1 wherein said curette tube is disconnectable from saidstopcock and said stopcock is disconnectable from said aspirator. 4.Apparatus as described in claim 3, wherein said curette tube has apredetermined diameter size of 7 to 8 mm for pregnancies up to 4 weeksduration, of 8 to 9 mm for pregancies from 4 to 6 weeks duration, and 9to 10 mm for pregnancies from 6 to 12 weeks duration.
 5. Apparatus asdescribed in claim 4 wherein said distal opening is substantially ovalin shape.